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WO2004060351A3 - Formulation pharmaceutique ayant un agent actif insoluble - Google Patents

Formulation pharmaceutique ayant un agent actif insoluble Download PDF

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Publication number
WO2004060351A3
WO2004060351A3 PCT/US2003/041703 US0341703W WO2004060351A3 WO 2004060351 A3 WO2004060351 A3 WO 2004060351A3 US 0341703 W US0341703 W US 0341703W WO 2004060351 A3 WO2004060351 A3 WO 2004060351A3
Authority
WO
WIPO (PCT)
Prior art keywords
active agent
pharmaceutical formulation
pulmonary administration
insoluble active
particulates
Prior art date
Application number
PCT/US2003/041703
Other languages
English (en)
Other versions
WO2004060351A2 (fr
Inventor
Thomas E Tarara
Jeffry G Weers
Original Assignee
Nektar Therapeutics
Thomas E Tarara
Jeffry G Weers
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
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Priority to MXPA05007158A priority Critical patent/MXPA05007158A/es
Priority to HU0500846A priority patent/HUP0500846A3/hu
Priority to EP03800395.0A priority patent/EP1589947B2/fr
Priority to ES03800395T priority patent/ES2589578T5/es
Priority to JP2004564917A priority patent/JP2006513236A/ja
Application filed by Nektar Therapeutics, Thomas E Tarara, Jeffry G Weers filed Critical Nektar Therapeutics
Priority to EA200501001A priority patent/EA200501001A1/ru
Priority to BR0317810-2A priority patent/BR0317810A/pt
Priority to CA2511523A priority patent/CA2511523C/fr
Priority to AU2003300137A priority patent/AU2003300137A1/en
Publication of WO2004060351A2 publication Critical patent/WO2004060351A2/fr
Publication of WO2004060351A3 publication Critical patent/WO2004060351A3/fr
Priority to NO20053076A priority patent/NO20053076L/no

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Dispersion Chemistry (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne une formulation pharmaceutique destinée à être administrée par voie pulmonaire contenant des particules comprenant une particule d'agent actif d'une matrice lipidique, l'agent actif faisant preuve d'une solubilité dans l'eau inférieure à 1,0 mg/ml. Selon une variante, au moins 90 % des particules d'agent actif dans la formulation pharmaceutique ont un diamètre géométrique inférieur à 3 µm. Selon une autre variante, l'agent actif insoluble comprend une amphotéricine B. Les particules présentent une taille et une forme permettant l'administration pulmonaire profonde de la formulation pharmaceutique sous forme d'aérosol.
PCT/US2003/041703 2002-12-31 2003-12-31 Formulation pharmaceutique ayant un agent actif insoluble WO2004060351A2 (fr)

Priority Applications (10)

Application Number Priority Date Filing Date Title
AU2003300137A AU2003300137A1 (en) 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration
HU0500846A HUP0500846A3 (en) 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration
EP03800395.0A EP1589947B2 (fr) 2002-12-31 2003-12-31 Formulation pharmaceutique ayant un agent actif insoluble
ES03800395T ES2589578T5 (es) 2002-12-31 2003-12-31 Formulación farmacéutica con un agente activo insoluble para administración pulmonar
JP2004564917A JP2006513236A (ja) 2002-12-31 2003-12-31 不溶性活性物質を伴う医薬製剤
MXPA05007158A MXPA05007158A (es) 2002-12-31 2003-12-31 Formulacion farmaceutica con un agente activo insoluble.
EA200501001A EA200501001A1 (ru) 2002-12-31 2003-12-31 Фармацевтический состав с нерастворимым активным агентом
BR0317810-2A BR0317810A (pt) 2002-12-31 2003-12-31 Formulação farmacêutica, e, método de fabricar a mesma
CA2511523A CA2511523C (fr) 2002-12-31 2003-12-31 Formulation pharmaceutique ayant un agent actif insoluble
NO20053076A NO20053076L (no) 2002-12-31 2005-06-23 Farmasoytisk formulering med en uloselig aktiv forbindelse.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US43721002P 2002-12-31 2002-12-31
US60/437,210 2002-12-31

Publications (2)

Publication Number Publication Date
WO2004060351A2 WO2004060351A2 (fr) 2004-07-22
WO2004060351A3 true WO2004060351A3 (fr) 2004-09-30

Family

ID=32713146

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/041703 WO2004060351A2 (fr) 2002-12-31 2003-12-31 Formulation pharmaceutique ayant un agent actif insoluble

Country Status (18)

Country Link
US (1) US20040156792A1 (fr)
EP (1) EP1589947B2 (fr)
JP (1) JP2006513236A (fr)
KR (1) KR20050095838A (fr)
CN (1) CN1741789A (fr)
AU (1) AU2003300137A1 (fr)
BR (1) BR0317810A (fr)
CA (1) CA2511523C (fr)
EA (1) EA200501001A1 (fr)
ES (1) ES2589578T5 (fr)
HU (1) HUP0500846A3 (fr)
MX (1) MXPA05007158A (fr)
NO (1) NO20053076L (fr)
PL (1) PL378270A1 (fr)
PT (1) PT1589947T (fr)
TR (1) TR200502522T2 (fr)
WO (1) WO2004060351A2 (fr)
ZA (1) ZA200505155B (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
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US9084944B2 (en) 2010-09-03 2015-07-21 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9084976B2 (en) 2010-09-03 2015-07-21 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9248584B2 (en) 2010-09-24 2016-02-02 Bend Research, Inc. High-temperature spray drying process and apparatus

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US20060165606A1 (en) * 1997-09-29 2006-07-27 Nektar Therapeutics Pulmonary delivery particles comprising water insoluble or crystalline active agents
US6565885B1 (en) * 1997-09-29 2003-05-20 Inhale Therapeutic Systems, Inc. Methods of spray drying pharmaceutical compositions
US8404217B2 (en) 2000-05-10 2013-03-26 Novartis Ag Formulation for pulmonary administration of antifungal agents, and associated methods of manufacture and use
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US7871598B1 (en) 2000-05-10 2011-01-18 Novartis Ag Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use
DK1458360T3 (da) 2001-12-19 2011-08-29 Novartis Ag Pulmonær afgivelse af aminoglycosider
JP2006513235A (ja) * 2002-12-31 2006-04-20 ネクター セラピューティクス 真菌感染症療法のためのエアゾール化可能な医薬製剤
EP1635786A2 (fr) 2003-05-28 2006-03-22 Nektar Therapeutics Sechage par pulverisation d'une solution aqueuse alcoolique pour la fabrication d'une microparticule contenant un principe actif insoluble dans l'eau et ayant un enrobage partiel ou complet comprenant un acide amine ou un phospholipide
US8513204B2 (en) * 2004-06-21 2013-08-20 Novartis Ag Compositions comprising amphotericin B, mehods and systems
WO2006026502A1 (fr) * 2004-08-27 2006-03-09 The Dow Chemical Company Administration amelioree de compositions medicamenteuses pour le traitement d'infections parfois mortelles
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WO2010111132A2 (fr) 2009-03-27 2010-09-30 Bend Research, Inc. Procédé de séchage par pulvérisation
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AU2011320159B2 (en) * 2010-10-29 2016-12-22 Western University Of Health Sciences Ternary mixture formulations
JOP20120023B1 (ar) 2011-02-04 2022-03-14 Novartis Ag صياغات مساحيق جافة من جسيمات تحتوي على واحد أو اثنين من المواد الفعالة لعلاج امراض ممرات الهواء الانسدادية او الالتهابية
CN106061487A (zh) * 2014-02-03 2016-10-26 里兰斯坦福初级大学理事会 用于微粒递送锌原卟啉的制剂
PT3212169T (pt) 2014-10-31 2021-05-06 Bend Res Inc Processo para formar domínios ativos dispersos numa matriz
CN104587457B (zh) * 2015-01-13 2017-03-22 广东海大畜牧兽医研究院有限公司 一种利用难溶或不溶蛋白、多肽抗原制备纳米微粒疫苗的方法
EP3393565B1 (fr) * 2015-12-24 2023-05-24 Philip Morris Products S.A. Système de distribution de poudre de nicotine
JP2019509985A (ja) 2016-02-01 2019-04-11 インカーダ セラピューティクス， インコーポレイテッド 心房細動を含む心不整脈を管理するための吸入薬物療法との電子的監視の組み合せ
KR20200003199A (ko) 2017-05-10 2020-01-08 인카다 테라퓨틱스, 인크. 폐 투여에 의해 심장 병태를 치료하기 위한 단위 용량, 에어로졸, 키트 및 방법
BR112019025635A2 (pt) * 2017-06-28 2020-06-23 Philip Morris Products S.A. Recipiente com partículas para uso com inalador
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9084944B2 (en) 2010-09-03 2015-07-21 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9084976B2 (en) 2010-09-03 2015-07-21 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9205345B2 (en) 2010-09-03 2015-12-08 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9358478B2 (en) 2010-09-03 2016-06-07 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9248584B2 (en) 2010-09-24 2016-02-02 Bend Research, Inc. High-temperature spray drying process and apparatus

Also Published As

Publication number Publication date
EA200501001A1 (ru) 2005-12-29
KR20050095838A (ko) 2005-10-04
NO20053076D0 (no) 2005-06-23
US20040156792A1 (en) 2004-08-12
CA2511523A1 (fr) 2004-07-22
PT1589947T (pt) 2016-09-05
BR0317810A (pt) 2005-11-29
ES2589578T5 (es) 2019-07-23
AU2003300137A1 (en) 2004-07-29
WO2004060351A2 (fr) 2004-07-22
HUP0500846A3 (en) 2008-10-28
ZA200505155B (en) 2006-04-26
EP1589947B8 (fr) 2016-08-24
MXPA05007158A (es) 2005-09-21
JP2006513236A (ja) 2006-04-20
EP1589947B1 (fr) 2016-06-15
HUP0500846A2 (en) 2008-05-28
EP1589947A2 (fr) 2005-11-02
CA2511523C (fr) 2013-10-15
NO20053076L (no) 2005-09-13
ES2589578T3 (es) 2016-11-15
EP1589947B2 (fr) 2019-01-30
CN1741789A (zh) 2006-03-01
TR200502522T2 (tr) 2005-09-21
PL378270A1 (pl) 2006-03-20

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